An Evaluation of the Impact of Pharmacist Comprehensive Medication Management With Pharmacogenomic Results to Improve Depression Outcomes in Community Pharmacies. (COMPASS-PGx)

Genotype-guided Comprehensive Medication Management to Improve Depression Outcomes in Pennsylvania

The goal of this prospective, randomized clinical trial is to learn whether pharmacogenomic (PGx)-guided comprehensive medication management delivered by pharmacists in community pharmacies will improve antidepressant treatment outcomes.

The primary aim is to determine whether comprehensive medication management with review of PGx testing results improves depression symptoms, compared with usual care.

Participants 18 years of age or older who have undergone PGx testing (e.g. through an independent biobanking study (Pitt+Me Discovery) who require initiation or adjustment of antidepressant therapy will be randomly assigned to receive either PGx-guided comprehensive medication management or usual care. Those who receive usual care will receive their PGx results at the end of the study. Researchers will compare the groups to assess whether PGx-guided care provided in partnership with community pharmacists and prescribers results in better depression and medication outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Pharmacogenetics; Community Pharmacy Services; Depression - Major Depressive Disorder; Pharmacogenomic Drug Interaction
• Intervention / Treatment: Other: Comprehensive medication management with PGx testing results; Other: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda Prebehalla, RN; Phone Number: (412) 624-8129; Email: CompassPGx@pitt.edu
• Study Contact Backup: Name: Philip E Empey, PharmD, PhD; Phone Number: (412) 624-7219; Email: compasspgx@pitt.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh
      • Contact: Philip E Empey, PharmD, PhD; Phone Number: (412) 648-7219; Email: CompassPGx@pitt.edu
      • Contact: Rhianna Ericson, MPH; Phone Number: (412) 624-8679; Email: CompassPGxx@pitt.edu
      • Sub-Investigator: Mylynda Massart, MD, PhD
      • Sub-Investigator: Kim Coley, PharmD
      • Sub-Investigator: Lucas Berenbrok, PharmD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

INCLUSION CRITERIA:

• At targeted community pharmacy for:

  • New prescription or change in dose/schedule of SSRI (citalopram, escitalopram, sertraline, paroxetine), OR
  • Concurrent SSRI (citalopram, escitalopram, sertraline, paroxetine) and new prescription/change in SNRI (desvenlafaxine, duloxetine, and venlafaxine) / bupropion.
• Depressive symptoms confirmed by PHQ8 assessment (>5 indicating at least mild depressive symptoms)
• UPMC patient (or able/willing to become one) and has UPMC provider (or able/willing to obtain one)
• Signed consent to join Pitt+Me Discovery biobanking research study.
• English-speaking

EXCLUSION CRITERIA:

• Inability to receive CMM at specific pharmacy/pharmacist
• Comorbid diagnosis of schizophrenia (patient-reported)
• Untreated sleep disorder (patient-reported)
• Pitt+Me Discovery participant who has elected to not receive return of results, or who has already received results previously

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comprehensive medication management with PGx testing results; Participants will have a study visit with a community pharmacist for comprehensive medication management with review of PGx testing results.	Other: Comprehensive medication management with PGx testing results; A comprehensive medication management with PGx testing includes a pharmacist-provided review of health history, past/current medications, and assessment of potential medication related problems. A review of PGx testing results will be integrated to identify any PGx-related medication issues. Recommendations will then be made to study participants' providers (regular care team) for any decisions regarding potential therapy changes.
Other: Usual care; Participants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.	Other: Usual Care; Participants will receive no study intervention (usual care) and will have a comprehensive medication management with review of PGx testing results at the end of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire (PHQ-8) score	The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure assessing depressive symptoms. Each item is scored from 0-3, producing a total score of 0-24, with higher scores indicating more severe depressive symptoms. Standard severity categories are minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-24).	Baseline, 6 Weeks, 12 Weeks, 6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) score	The Extent of Adherence and Reasons for Nonadherence Survey (Voils et al.) is a validated self-report measure assessing medication adherence over the past 7 days. It is scored on a 1-5 Likert scale and averaged to produce a continuous score, with higher scores indicating better adherence. The Reasons for Nonadherence scale assesses specific barriers to taking medication as prescribed, with items rated on a 1-5 scale and assessed individually to identify the degree to which each barrier contributed to missed doses.	Baseline, 6 Months
Change in Generalized Anxiety Disorder Assessment (GAD-7) score	The Generalized Anxiety Disorder Assessment (GAD-7) is a 7-item self-report measure assessing anxiety symptoms over the past two weeks, with items scored 0-3 for a total score of 0-21; higher scores indicate more severe anxiety, categorized as minimal (0-4), mild (5-9), moderate (10-14), and severe (15-21).	Baseline, 6 Weeks, 12 Weeks, 6 Months
Proportion of pharmacist recommendations were accepted	Proportion of pharmacist recommendations to address medication-related problems that were accepted by providers as assessed by EHR and fill data review.	6 months
Change in frequency of CPIC/FDA guideline concordant prescribing	Change in frequency of concordance of participant medication regimen with pharmacogenomics prescribing recommendations according to the Clinical Pharmacogenomics Implementation Consortium (CPIC) and U.S. Food & Drug Administration (FDA) guidelines using electronic health record data.	Baseline, 6 Months
Number of adverse events as assessed using the Frequency, Intensity, and Burden of Side Effect rating scale (FIBSER).	The Frequency, Intensity, and Burden of Side Effect Rating Scale (FIBSER) is a 3-item self-report measure assessing medication side effects. It evaluates the frequency, intensity, and functional burden of side effects over the past week, with each item rated on a 0-6 scale; higher scores indicate more frequent, severe, or burdensome side effects. Clinically, a total score of 0-2 typically requires no change in treatment, 3-4 side effects may warrant targeted management, and 5-6 indicates that treatment modification should be considered to improve tolerability and adherence.	Baseline, 6 Weeks, 12 Weeks, 6 Months
Frequency of Actionable Genotypes	Frequency of actionable genotypes (in the entire study population) based on report of a genotype-predicted phenotype. Actionable genotypes are defined as those with recommendations for a change in prescribing by a CPIC (Clinical Pharmacogenetics Implementation Consortium) guidelines or FDA recommendations.	6 months
Number of participant medications with PGx guidance based on PGx testing results.	This measure counts the number of a participant's medications for which pharmacogenomic (PGx) guidance is available based on PGx testing results. Medications with PGx guidance may have dosing recommendations, alternative drug options, or monitoring considerations informed by the participant's genetic profile.	6 months
Change in healthcare utilization	Change in participant ER visits, hospitalizations, urgent care visits, specialist appointments, primary care appointments, and unplanned care using UPMC EHR data.	From Baseline to 6 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Community pharmacists' needs for expert support in deploying PGx	Community pharmacists' needs for expert support in deploying PGx Number and types of questions asked by community pharmacists to PGx experts on study team through the duration of the study.	6 Months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Pennsylvania Department of Health
• Investigators: Principal Investigator: Philip E Empey, PharmD, PhD, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 28, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: antidepressants; community pharmacy; pharmacist; pharmacogenomics; medication review; precision medicine; PGx; Comprehensive medication management; pharmacogenomic testing; management of depression
• Other Study ID Numbers: STUDY21120100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No